Adverse events associated with the bridge occlusion balloon for lead extraction: A MAUDE database study

Contractor, Tahmeed; Bhardwaj, Rahul; Mandapati, Ravi; Kotak, Kamal; Garg, Jalaj

doi:10.1016/j.hrthm.2022.06.035

Cited by 4 publications

(3 citation statements)

References 3 publications

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“…The safety profile of the BOB was recently studied using the MAUDE database. 18 In our first patient, the BOB may have stopped the bleeding and allowed time for clot formation. The surgical exploration few hours later confirmed that no active bleeding was seen.…”

Section: Discussionmentioning

confidence: 84%

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Superior vena cava tear during transvenous lead extraction: Medical management in hemodynamically stable patients

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Strubé

Jacques

et al. 2023

Pacing Clinical Electrophis

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Introduction Superior vena cava (SVC) tear is the most lethal complication during transvenous lead extraction (TLE) with a mortality rate as high as 50%. Treatment involves aggressive attempts to maintain cardiac output and immediate sternotomy to localize and repair the vascular tear. Occlusion balloons have been developed to provisionally occlude the lacerated SVC and to provide hemodynamic stability allowing time for surgery. In case of mediastinal hematoma without hemodynamic instability, the strategy remains unclear. Methods and Results We describe two cases of SVC tear during TLE. The first case was a 60‐year‐old man who presented with a right ventricular single‐chamber defibrillator lead fracture and innominate vein stenosis. The RV lead was removed using a laser sheath causing a mediastinal hematoma with no active bleeding during surgical exploration few hours later. The second case was a 28‐year‐old man that presented with a right atrial (RA) lead fracture and RV lead insulation failure in a dual‐chamber defibrillator (ICD). Conclusion Both the RA and RV leads were removed with mechanical sheaths, and a mediastinal hematoma was medically managed.

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Section: Discussionmentioning

confidence: 84%

“…Since the initial management of these lacerations is nowadays rapid deployment of the BOB and immediate surgical intervention, few data are available on the management of smaller lacerations without hemodynamic instability. The safety profile of the BOB was recently studied using the MAUDE database 18 …”

Section: Discussionmentioning

confidence: 99%

Superior vena cava tear during transvenous lead extraction: Medical management in hemodynamically stable patients

Domain

Strubé

Jacques

et al. 2023

Pacing Clinical Electrophis

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“…Upon manual review, 135 articles with unclear queries 32–164 and 120 with incomplete queries 165–284 were excluded. Ultimately, 60 executable queries were found 5,10,285–342 . A comprehensive flowchart of this selection process is depicted in Figure 1.…”

Section: Methodsmentioning

confidence: 99%

Assessing the Reproducibility of Research Based on the Food and Drug Administration Manufacturer and User Facility Device Experience Data

Li,

Feng,

Gong

et al. 2024

J Patient Saf

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Objective This article aims to assess the reproducibility of Manufacturer and User Facility Device Experience (MAUDE) data-driven studies by analyzing the data queries used in their research processes. Methods Studies using MAUDE data were sourced from PubMed by searching for “MAUDE” or “Manufacturer and User Facility Device Experience” in titles or abstracts. We manually chose articles with executable queries. The reproducibility of each query was assessed by replicating it in the MAUDE Application Programming Interface. The reproducibility of a query is determined by a reproducibility coefficient that ranges from 0.95 to 1.05. This coefficient is calculated by comparing the number of medical device reports (MDRs) returned by the reproduced queries to the number of reported MDRs in the original studies. We also computed the reproducibility ratio, which is the fraction of reproducible queries in subgroups divided by the query complexity, the device category, and the presence of a data processing flow. Results As of August 8, 2022, we identified 523 articles from which 336 contained queries, and 60 of these were executable. Among these, 14 queries were reproducible. Queries using a single field like product code, product class, or brand name showed higher reproducibility (50%, 33.3%, 31.3%) compared with other fields (8.3%, P = 0.037). Single-category device queries exhibited a higher reproducibility ratio than multicategory ones, but without statistical significance (27.1% versus 8.3%, P = 0.321). Studies including a data processing flow had a higher reproducibility ratio than those without, although this difference was not statistically significant (42.9% versus 17.4%, P = 0.107). Conclusions Our findings indicate that the reproducibility of queries in MAUDE data-driven studies is limited. Enhancing this requires the development of more effective MAUDE data query strategies and improved application programming interfaces.

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Reply to the Editor— Estimated prevalences of serious adverse events associated with the AtriClip device for left atrial appendage occlusion

et al. 2023

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Adverse events associated with the bridge occlusion balloon for lead extraction: A MAUDE database study

Cited by 4 publications

References 3 publications

Superior vena cava tear during transvenous lead extraction: Medical management in hemodynamically stable patients

Superior vena cava tear during transvenous lead extraction: Medical management in hemodynamically stable patients

Assessing the Reproducibility of Research Based on the Food and Drug Administration Manufacturer and User Facility Device Experience Data

Reply to the Editor— Estimated prevalences of serious adverse events associated with the AtriClip device for left atrial appendage occlusion

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